Package leaflet: Information for the patient

NIFEDIPINE DOC 30 mg prolonged-release coated tablets, 60 mg prolonged-release coated tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NIFEDIPINE DOC is and what it is used for
What you need to know before taking NIFEDIPINE DOC
How to take NIFEDIPINE DOC
Possible side effects
How to store NIFEDIPINE DOC
Contents of the pack and other information

1. What NIFEDIPINA DOC is and what it is used for

NIFEDIPINA DOC contains the active substance nifedipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists).
NIFEDIPINA DOC is used to treat high blood pressure (hypertension) or chronic stable angina pectoris (exertional angina), which is characterized by severe chest pain due to insufficient blood and oxygen supply to the heart (usually occurring after physical exertion).

2. What you should know before taking NIFEDIPINE DOC

Do not take NIFEDIPINE DOC

if you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6);
if you have cardiogenic shock (sudden drop in blood pressure) characterized by difficulty breathing, paleness, cold sweating, and dry mouth;
if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections. In this case, nifedipine levels in the blood may become insufficient.

Warnings and precautions
Talk to your doctor or pharmacist before taking NIFEDIPINE DOC.
Take this medicine with caution and always under medical supervision in the following cases:

if you have very low blood pressure (systolic pressure below 90 mmHg). In this case, your doctor needs to monitor your blood pressure regularly;
if you have reduced heart function, for example congestive heart failure. In this case, consult your doctor if you develop swelling in arms or legs (peripheral edema);
if you have been diagnosed with severe narrowing of the aortic valve of the heart;
if you are pregnant, if during pregnancy you experience an emergency condition such as eclampsia, a serious, potentially life-threatening illness characterized by seizures, or if you are receiving intravenous magnesium sulfate during pregnancy (this may cause excessive drop in blood pressure, leading to harm to both mother and fetus);
if you are breastfeeding;
if you have impaired liver function. In this case, careful monitoring and possibly a dose reduction may be required;
if you are taking other medicines that may increase nifedipine blood levels. In this case, your doctor must closely monitor your blood pressure and, if necessary, reduce the dose of the medicine (see section Other medicines and NIFEDIPINE DOC);
if you are concurrently taking beta-blockers or other blood pressure-lowering medicines (antihypertensives);
if you have or are at risk of developing diabetes. In this case, blood glucose levels should be carefully monitored and, if high levels occur, treatment should be discontinued;
if you have undergone intestinal surgery known as Kock pouch (ileostomy after proctocolectomy);
if you have narrowing of the stomach or intestine (severe gastrointestinal tract stenosis);
if you suffer from high blood pressure (malignant hypertension), if you have severe kidney dysfunction (irreversible renal failure) associated with reduced blood volume (hypovolemia), and need mechanical blood filtration (dialysis).

If during treatment with this medicine you experience chest pain (angina pectoris), consult your doctor.
This medicine may interfere with radiological test results (radiological examinations using barium contrast), leading to false positive results (which may be interpreted as polyps).
Other medicines and NIFEDIPINE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine in combination with medicines containing rifampicin, an antibiotic used to treat certain types of infections (see Do not take NIFEDIPINE DOC).
Be especially careful and inform your doctor if you are taking the following medicines:

macrolide antibiotics, such as erythromycin;
medicines used to treat AIDS, such as ritonavir;
medicines used to treat fungal infections, such as ketoconazole;
fluoxetine and nefazodone, used to treat depression;
quinupristin and dalfopristin, used to treat infections;
valproic acid, phenytoin, carbamazepine, and phenobarbital, used to treat epilepsy;
cimetidine and cisapride, used for stomach disorders;
medicines to lower blood pressure (diuretics, beta-blockers, ACE inhibitors, angiotensin receptor antagonists, other calcium antagonists, α-blockers, α-methyldopa);
digoxin, a medicine for heart conditions;
quinidine, used to treat heart rhythm disorders;
tacrolimus, used to prevent organ rejection after transplantation;
intravenous magnesium sulfate during pregnancy (may cause excessive drop in blood pressure, leading to harm to both mother and fetus).

NIFEDIPINE DOC with food and drinks
Do not consume grapefruit or grapefruit juice during treatment with NIFEDIPINE DOC. Grapefruit and grapefruit juice may increase nifedipine blood concentrations, which could lead to an unpredictable increase in the blood pressure-lowering effect of NIFEDIPINE DOC.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take NIFEDIPINE DOC during pregnancy unless strictly necessary. Consult your doctor if you are pregnant or planning a pregnancy.
Breastfeeding
This medicine is not recommended if you are breastfeeding, as nifedipine passes into breast milk.
Fertility
In men experiencing infertility with in vitro fertilization (an assisted reproductive technique), and when no other causes can be identified, consider the possibility that calcium antagonists such as nifedipine may be contributing to the problem.
Driving and using machines
The use of NIFEDIPINE DOC may affect your ability to drive or operate machinery, as side effects such as dizziness may occur, especially at the beginning of treatment, when changing medication, or when consuming alcohol. If this happens, avoid driving or using machinery.
NIFEDIPINE DOC contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take NIFEDIPINA DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in adults is 1 tablet of 30 mg once daily.
Your doctor will adjust the dose and duration of treatment according to your condition.
In the treatment of stable chronic angina, your doctor may gradually increase the dose up to a
maximum of 120 mg once daily, taken in the morning.
In the treatment of high blood pressure, your doctor may gradually increase the dose up to a
maximum of 60 mg once daily, taken in the morning.

Use in patients with liver problems
If you have liver problems, your doctor must monitor your blood pressure and, in more severe cases, may need to reduce
the dose.

Use in children and adolescents
There is no experience with the use of NIFEDIPINA DOC in children and adolescents. Therefore, NIFEDIPINA DOC is not
recommended for use in children and adolescents under 18 years of age.

Method of administration
Take the tablets whole, without chewing or breaking them, with a little water in the morning, regardless of
meals.
Remove the tablet from the blister pack only at the time of administration, avoiding prolonged exposure to light and
moisture.

If you take more NIFEDIPINA DOC than you should
If you (or someone else) have ingested more tablets at the same time, or if you suspect that a child has
swallowed any tablets, consult a doctor immediately. Overdose may cause disturbances of consciousness up to coma, low blood pressure, changes in heart rhythm, high blood sugar levels (hyperglycaemia), decreased blood pH (metabolic acidosis), reduced oxygen supply (hypoxia), and severe heart problems such as cardiogenic shock with fluid accumulation in the lungs (pulmonary oedema).
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Bring this leaflet, any remaining tablets, and the original packaging with you to the hospital or doctor so that they know which tablets have been taken.

If you forget to take NIFEDIPINA DOC
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking NIFEDIPINA DOC
The duration of treatment should be determined by your doctor. If necessary, your doctor will gradually discontinue
treatment, especially if you are taking high doses, to avoid rapid increases in blood pressure or circulation problems.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

headache;
swelling due to fluid accumulation;
blood vessel relaxation (vasodilation);
constipation;
general feeling of being unwell.

Uncommon (may affect up to 1 in 100 people)

allergic reaction;
swelling due to allergic fluid accumulation;
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (potentially life-threatening);
anxiety, sleep disorders;
dizziness, one-sided headache (migraine), vertigo, tremor;
vision disorders;
increased heart rate, heightened awareness of heartbeat;
low blood pressure, transient loss of consciousness;
nosebleeds and sensation of nasal congestion;
abdominal and intestinal pain, nausea, difficulty digesting, excessive gas production in the intestine, dry mouth;
transient increase in liver enzymes;
skin irritation;
muscle cramps, joint swelling;
excessive urine production, difficulty urinating;
problems achieving and/or maintaining an erection;
non-specific pain, chills.

Rare (may affect up to 1 in 1,000 people)

itching, hives, skin rash;
tingling and numbness, burning sensation and pain like needles on the skin;
gum swelling.

Not known (frequency cannot be estimated from the available data)

lack of certain blood cells called granulocytes;
decrease in certain types of white blood cells;
severe allergic reaction;
high blood sugar levels (hyperglycaemia);
decreased sensitivity, drowsiness;
eye pain;
chest pain due to heart problems (angina pectoris);
shortness of breath;
difficulty swallowing;
formation of foreign bodies (bezoars) in the stomach or intestine;
intestinal problems (intestinal ulcer or intestinal obstruction);
vomiting, heartburn and indigestion;
yellowish discoloration of the skin and whites of the eyes due to liver malfunction;
blistering or peeling of the skin or mucous membranes (toxic epidermal necrolysis);
skin sensitivity to sunlight;
skin condition characterized by bleeding (purpura);
joint and muscle pain;
reduced haemoglobin levels (a protein that carries oxygen within red blood cells) in the blood;
reduced platelet count;
liver inflammation;
sexual dysfunction;
sore throat, cough, sweating, fever;
joint stiffness and inflammation;
breathing difficulty.

In dialysis patients suffering from excessively high blood pressure and low blood volume, a severe drop in blood pressure may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NIFEDIPINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
It is advisable not to expose the tablets to direct sunlight for prolonged periods.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIFEDIPINA DOC contains
NIFEDIPINA DOC 30 mg prolonged-release coated tablets

The active substance is nifedipine. Each prolonged-release coated tablet contains 30 mg of nifedipine.
The other components are: povidone, talc, hypromellose, carbomer 974P, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, iron oxide (E 172), titanium dioxide (E 171), macrogol 4000, polymethacrylate (eudragit “E”).

NIFEDIPINA DOC 60 mg prolonged-release coated tablets

The active substance is nifedipine. Each prolonged-release coated tablet contains 60 mg of nifedipine.
The other components are: povidone, talc, hypromellose, carbomer 974P, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, iron oxide (E 172), titanium dioxide (E 171), macrogol 4000, polymethacrylate (eudragit “E”).

Description of the appearance of NIFEDIPINA DOC and contents of the pack
Pack containing 14 prolonged-release coated tablets.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan
Manufacturer
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero (MO)